| CTRI Number |
CTRI/2017/03/008123 [Registered on: 16/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
10/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Laryngoscopic view with different operating table height. |
|
Scientific Title of Study
|
Influence of operating table height on laryngeal view during direct laryngoscopy: A randomized prospective crossover trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr kailashnath Shenoy |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
|
| Fax |
|
| Email |
kailasnathshenoy@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Yogesh K Gaude |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
|
| Fax |
|
| Email |
yogeshgaude@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kriti Puri |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
|
| Fax |
|
| Email |
drkriti1207@gmail.com |
|
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Source of Monetary or Material Support
|
| PG Thesis fund , Manipal University, Manipal, Karnataka , India. |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kailashnath Shenoy |
Kasturba Hospital, Manipal |
Department of Anaesthesiology, OT Complex, Kasturba Hospital,Manipal University, Madhavnagr, Manipal Udupi KARNATAKA |
08904380406
kailasnathshenoy@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
American Society Of Anesthesiologists physical
status 1 and 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laryngoscopy view above xiphoid process |
Group A- Initial laryngoscopy with table height adjusted to place patient’s forehead at a level 5cm below xiphoid process (level B). Following this the operating table height will be brought to the level of xiphoid process (level X) in accordance to level marked beforehand on the IV stand. Subsequent laryngoscopy and intubation with table height adjusted to place patient’s forehead 5 cm above the level of laryngoscopist’ xiphoid process (level A). |
| Comparator Agent |
Laryngoscopy view at xiphoid process |
Group X - Initial laryngoscopy will be performed at level B. Subsequently operating table height will be adjusted to level A and laryngoscopy will be performed. Next the table will be brought to level X and laryngoscopy and intubation will be done at this level. |
| Comparator Agent |
Laryngoscopy view below xiphoid process |
Group B – Initial laryngoscopy with table height adjusted to place patient’s forehead 5cm above the level of laryngoscopist’ xiphoid process (level A). Next the level of the operating table will be brought to the level of xiphoid process and laryngoscopy will be performed (level X). Subsequent laryngoscopy and intubation with table height adjusted to place patient’s forehead 5 cm below the level of laryngoscopist’ xiphoid process (level B). |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age between 18-60 years of either sex
2) ASA PS 1 and 2
3) BMI 25 to 30 kg/m2
4) Elective general surgical or gynecological abdominal, urologic or orthopedic surgery requiring general anesthesia.
|
|
| ExclusionCriteria |
| Details |
1) Those aged <18 or >60 years
2) Patients who are obese( Body mass index > 30)
3) Patients with congenital or acquired airway abnormalities
4) Those with loose teeth ,buck teeth or edentulous jaws
5) Those with increased risk of aspiration
6) Those with anticipated difficult airway as evidenced by modified Mallampati Class 3 or 4, inability to insinuate tip of 1 finger into temporo-mandibular joint, mouth opening < 2 finger breadth, thyromental distance < 3 finger breadth.
7) Oropharyngeal/neck masses.
8) Limited neck movement
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of the laryngeal view |
During Layngoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ease of intubation and anesthesiologist’s comfort |
During Layngoscopy |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/10/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Maintenance of a patent airway is a
fundamental responsibility of the anesthesiologist. Tracheal intubation remains
one of the commonest means of establishing an airway. Placing the head and neck
in the sniffing position has traditionally been
considered important for obtaining good glottic visualization during direct
laryngoscopy. Direct laryngoscopy is used to facilitate tracheal intubation under
vision. Successful direct laryngoscopy depends on achieving a line of sight
from the maxillary teeth to the larynx 1.It has been clearly
established in several studies that proper positioning of head and neck is one
of the most important step towards laryngoscopy and tracheal intubation which
helps in obtaining a good glottic view, thus minimizing the rate of tracheal injury, duration of the procedure, repeated
attempts at laryngoscopy and intubation- ultimately reducing the overall rate
of trauma and further complications. Best laryngoscopic views are obtained when
oropharyngo-laryngeal axes come in a straight line. The ‘sniff’ position has
been advocated as a standard for direct laryngoscopy. In this position, the
neck is flexed on the chest and the head is extended on the atlanto-occipital
joint by elevating the head on a pillows 2,3.The ‘sniff’ position is usually the best starting position
for direct laryngoscopy. In the ‘sniff’ position, the cervical spine below C5
is relatively straight, there is increasing flexion from C4 to C2, and the head
is fully extended (occipito– atlanto–axial complex) 4. Neck flexion between C2 and C4 is achieved by elevation
of the head.
Operating table height can influence task performance and
physical/mental workload5, 6 .There have been
few studies of the correlation between the operating table height and the
quality of laryngeal view during direct laryngoscopic (DL) intubation7.
In an editorial on anesthesiologist stature and patient positioning, Heath7 highlighted the
benefits of using an adjustable operating table and the ergonomic benefits of
different heights—high during cannulation to prevent back discomfort, a bit
lower for airway management, and even lower for short trainees. It has been
suggested that the patient’s face should be placed at the height of the anesthesiologist’s
xiphoid process for comfortable intubation without requiring the anesthesiologist
to bend his/her back 8-10 and that
the physician’s eyes should be placed 1 foot (30 cm) above the patient’s face
to provide proper angles and distances for laryngoscopy 11. However, these results
are based on clinical experience rather than scientific validation.
The
aim of this study was to evaluate the quality of the laryngeal view (primary
variable), ease of intubation and anesthesiologist’s comfort (secondary
variable) associated with three different operating table heights during DL and
tracheal intubation. Based on our clinical experience, we hypothesized that
higher operating tables would improve the quality of the laryngeal view and
decrease anesthesiologist’s discomfort during tracheal intubation by reducing
the need to bend their neck or lower back when compared with lower operating
table height. |